TABLE 4.
Incidence of systemic solicited adverse events during the day of vaccination and each of the consecutive 4 days after the first, second and third vaccination
| Systemic adverse events |
HBAI20 (n = 1,345 days) |
HBVaxPro©‐10 µg (n = 435 days) |
P value | |
|---|---|---|---|---|
| Fever | Any | 10 (0.7%) | 2 (0.5%) | .771 |
| Severe | 1 (0.1%) | 1 (0.2%) | .985 | |
| Headache | Any | 89 (6.6%) | 25 (5.7%) | .595 |
| Severe | 0 (0.0%) | 1 (0.2%) | .552 | |
| Fatigue | Any | 142 (10.6%) | 42 (9.7%) | .655 |
| Severe | 2 (0.1%) | 0 (0.0%) | 1.000 | |
| Vomiting | Any | 1 (0.1%) | 1 (0.2%) | .985 |
| Severe | 0 (0.0%) | 0 (0.0%) | — | |
| Diarrhoea | Any | 28 (2.1%) | 4 (0.9%) | .168 |
| Severe | 0 (0.0%) | 0 (0.0%) | — |